The present invention relates generally to programmable automation of systems and devices used in a clinical laboratory, whereby an intelligent automation is introduced into an algorithm to allow the systems and devices to self-monitor after performing a first assay and to proceed with analysis of second and subsequent tier assays based on the results of tests done at the preceding stage of the algorithm. The method allows the system to respond appropriately to preceding results and eliminate tasks and assays that are unnecessary. In the practice of the invention, the algorithm provides a step-by-step procedure whereby only the relevant assays are carried out in sequence providing result of performed tests which are both rapid, complete and cost-effective.
The worldwide efforts to reduce the overall costs of medical care through the introduction of managed care and other strategic approaches have caused many clinical laboratories to consolidate into larger, more efficient entities that are aiming to implement wide-scale automation. The principles that are applied to automate the analytical process in clinical laboratories include, commercially available chemistry, hematology, immunoassay, nucleic acid systems, point-of-care analyzers and automated specimen processing systems. The development of automated instruments has enabled laboratories to process a much larger workload without a comparable increase in staff. Another benefit of automation is the reduction in the variability of results and errors of analysis of eliminating tasks that are repetitive and monotonous for a human and that can lead to inattention. The improved reproducibility and quality of laboratory tests thus owes much to the combination of well designed automated instrumentation with good analytical methods and effective quality assurance programs.
Automation has resulted in substantial cost savings because of the reduction in the number of staff needed to process the clinical test workload. However, these substantial cost savings have not had a significant impact on the overall cost of Medical care. In fact, the ease of automation may have indirectly resulted in ordering by prescription of a broad-spectrum of tests, including some unnecessary ones, rather than ordering selective tests that provide a complete diagnosis of a disease. In addition, the increasing fear of malpractice charges for misdiagnosis by the wary physician has encouraged an indiscriminate number of clinical tests to be ordered and carried out. Thus, there is an urgent need to develop systems that measure only the necessary assays but move between distinct modes of laboratory utilization without a prolonged transition period, to provide a complete and accurate diagnosis with the first procured sample.